Associate Director, Compliance – North America
Job Description:
• Serve as a trusted compliance partner to the Sales, Marketing, Market Access, and Medical teams, attending meetings and providing targeted compliance training that ensures alignment with company policies and regulatory requirements.
• Offer real-time guidance on commercial and scientific activities, HCP interactions, and promotional practices.
• Lead the HCP Engagement process, including annual planning, policy updates, FMV assessments, and process improvements to enhance efficiency and compliance.
• Collaborate across risk management functions (e.g., Legal, Finance, Procurement) and initiatives (e.g., Third-Party Risk Management (TPRM), Enterprise Risk Management (ERM)) to optimize due diligence and monitoring solutions.
• Prepare for and serve as secretary of the U.S. Compliance Committee, maintaining accurate records and tracking follow-ups to support committee effectiveness.
• Manage the North America Compliance Champion Program, fostering a culture of compliance through training, engagement initiatives, metric tracking, and continuous improvement efforts.
• Maintain expert-level knowledge of compliance-related laws, regulations, and industry guidance, including Anti-Kickback Statute, FDCA, HIPAA, Federal Sunshine Act (Open Payments), State Transparency Laws, and PhRMA Code.
• Lead compliance policy development, review, and updates, supporting the Policy Review Committee in overseeing a structured policy management framework.
• Design and deliver engaging compliance training programs that promote awareness and reinforce compliance obligations across the organization.
• Conduct live and remote compliance monitoring and support ongoing back-end monitoring activities, tracking and reporting compliance performance.
• Support and coordinate internal and external audits, ensuring adherence to compliance standards and supporting corrective actions as needed.
• Oversee the creation of appropriate tracking mechanisms based on problem identification and addressing instances of non-compliance and ensuring consistency in the application of disciplinary action.
• Use monitoring and audit data to identify trends, present insights to leadership, and drive compliance improvements.
• Regularly seek stakeholder feedback to enhance compliance support and refine training and communication strategies.
• Assist with the creation and maintenance of Legal and Compliance-related dashboards and reports and assist with the development, management and reporting of data analytics to manage compliance risks.
• Actively promote and reinforce a culture of integrity, ensuring compliance is embedded into daily business operations and decision-making.
• Manage compliance communication resources, including the ethics hotline and compliance intranet content, ensuring transparency and accessibility.
Requirements:
• Bachelor of Arts or Bachelor of Science required; J.D. or other advanced degree preferred but not required with 8 + years of combined experience in healthcare compliance, including in-house experience.
• Ability to work effectively in a global environment and good at managing work under a matrix organization structure and comparably complicated environment.
• Management experience and ability to mentor and supervise a team of professionals.
• Strong expertise in compliance with laws, regulations, and industry codes relevant to the development and commercialization of pharmaceutical products.
• Working knowledge and experience with U.S. healthcare fraud and abuse laws (e.g., Anti-kickback statute, False Claims Act), FDCA, FDA guidance, OIG Compliance Program Guidance, OIG advisory opinions, and federal and state transparency and compliance program disclosure laws, and U.S. and international industry codes (e.g., PhRMA, EFPIA, IFPMA).
• Excellent communication skills (oral and written; strong interpersonal skills in both one-on-one and group settings.
• Ability to maintain a high degree of confidentiality in dealing with sensitive matters.
• Acts with a sense of urgency, with high motivation and ability to take initiative, follow through and complete projects in a professional and expeditious manner.
• Strong presentation skills, including creating and delivering presentations to various size audiences at all levels of the organization.
• Strong analytical and problem-solving skills.
• Strong attention to detail and accuracy.
• Strong collaborative, interpersonal and oral communication skills.
Benefits:
• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness
• Annual bonus plan
• Discretionary equity awards
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• Serve as a trusted compliance partner to the Sales, Marketing, Market Access, and Medical teams, attending meetings and providing targeted compliance training that ensures alignment with company policies and regulatory requirements.
• Offer real-time guidance on commercial and scientific activities, HCP interactions, and promotional practices.
• Lead the HCP Engagement process, including annual planning, policy updates, FMV assessments, and process improvements to enhance efficiency and compliance.
• Collaborate across risk management functions (e.g., Legal, Finance, Procurement) and initiatives (e.g., Third-Party Risk Management (TPRM), Enterprise Risk Management (ERM)) to optimize due diligence and monitoring solutions.
• Prepare for and serve as secretary of the U.S. Compliance Committee, maintaining accurate records and tracking follow-ups to support committee effectiveness.
• Manage the North America Compliance Champion Program, fostering a culture of compliance through training, engagement initiatives, metric tracking, and continuous improvement efforts.
• Maintain expert-level knowledge of compliance-related laws, regulations, and industry guidance, including Anti-Kickback Statute, FDCA, HIPAA, Federal Sunshine Act (Open Payments), State Transparency Laws, and PhRMA Code.
• Lead compliance policy development, review, and updates, supporting the Policy Review Committee in overseeing a structured policy management framework.
• Design and deliver engaging compliance training programs that promote awareness and reinforce compliance obligations across the organization.
• Conduct live and remote compliance monitoring and support ongoing back-end monitoring activities, tracking and reporting compliance performance.
• Support and coordinate internal and external audits, ensuring adherence to compliance standards and supporting corrective actions as needed.
• Oversee the creation of appropriate tracking mechanisms based on problem identification and addressing instances of non-compliance and ensuring consistency in the application of disciplinary action.
• Use monitoring and audit data to identify trends, present insights to leadership, and drive compliance improvements.
• Regularly seek stakeholder feedback to enhance compliance support and refine training and communication strategies.
• Assist with the creation and maintenance of Legal and Compliance-related dashboards and reports and assist with the development, management and reporting of data analytics to manage compliance risks.
• Actively promote and reinforce a culture of integrity, ensuring compliance is embedded into daily business operations and decision-making.
• Manage compliance communication resources, including the ethics hotline and compliance intranet content, ensuring transparency and accessibility.
Requirements:
• Bachelor of Arts or Bachelor of Science required; J.D. or other advanced degree preferred but not required with 8 + years of combined experience in healthcare compliance, including in-house experience.
• Ability to work effectively in a global environment and good at managing work under a matrix organization structure and comparably complicated environment.
• Management experience and ability to mentor and supervise a team of professionals.
• Strong expertise in compliance with laws, regulations, and industry codes relevant to the development and commercialization of pharmaceutical products.
• Working knowledge and experience with U.S. healthcare fraud and abuse laws (e.g., Anti-kickback statute, False Claims Act), FDCA, FDA guidance, OIG Compliance Program Guidance, OIG advisory opinions, and federal and state transparency and compliance program disclosure laws, and U.S. and international industry codes (e.g., PhRMA, EFPIA, IFPMA).
• Excellent communication skills (oral and written; strong interpersonal skills in both one-on-one and group settings.
• Ability to maintain a high degree of confidentiality in dealing with sensitive matters.
• Acts with a sense of urgency, with high motivation and ability to take initiative, follow through and complete projects in a professional and expeditious manner.
• Strong presentation skills, including creating and delivering presentations to various size audiences at all levels of the organization.
• Strong analytical and problem-solving skills.
• Strong attention to detail and accuracy.
• Strong collaborative, interpersonal and oral communication skills.
Benefits:
• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness
• Annual bonus plan
• Discretionary equity awards
Apply tot his job
Apply To this Job